Health Resources and Services Administration, 76052-76053 [2012-30835]
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76052
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
796–2340, email: Christine.Lincoln@fda.
hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Public Workshop on Minimal
Residual Disease will be one of a series
of FDA workshops to establish
processes and procedures necessary to
qualify a prognostic biomarker, MRD, as
a possible response or efficacy
biomarker in a group of hematological
malignancies. Evaluation of clinical data
suggests that MRD can be established as
a potential surrogate endpoint for
pivotal clinical trials and drug approval
given its prominent role as a prognostic
indicator in certain subtypes of acute
and chronic leukemia. The Office of
Hematology and Oncology Products
plans to explore the potential utility of
MRD as a surrogate endpoint in acute
lymphoblastic leukemia (ALL)
(including the relapsed setting), CLL,
and acute myeloid leukemia (AML).
Given the diverse pathophysiology and
natural history of these diseases, and
current practice standards,
individualized consideration of MRD as
a surrogate endpoint is warranted. The
ALL workshop was held on April 18,
2012. The CLL and AML workshops are
scheduled for February 27, 2013, and
March 4, 2013, respectively.
tkelley on DSK3SPTVN1PROD with
II. Structure and Scope of the
Workshop
The workshop’s scope will extend to
the use of flow cytometry and the
molecular methods used to measure
minimal residual disease in patients
being treated for CLL. The workshop
will consist of formal presentations
examining the regulatory, scientific, and
clinical basis for use of biomarkers as
potential clinical trial endpoints in CLL
followed by discussions on issues
associated with use of an MRD
endpoint.
III. Attendance and Registration
FDA encourages patient advocates,
representatives from industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
There is no registration fee for the
public workshop. To register
electronically, please use the following
Web site: https://www.zoomerang.com/
Survey/WEB22GPA3U95QX (FDA has
verified the Web site address, but we are
not responsible for any subsequent
changes to the Web site after this
document publishes in the Federal
Register.) Seats are limited and
conference space will be filled in the
order in which registrations are
received. Onsite registration will be
VerDate Mar<15>2010
06:31 Dec 22, 2012
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available to the extent that space is
available on the day of the conference.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm.
Under the heading ‘‘Resources for You,’’
click on ‘‘Public Meetings at the FDA
White Oak Campus.’’
Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31044 Filed 12–21–12; 4:15 pm]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
ACTION:
Notice.
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of Title
44, United States Code, as amended by
the Paperwork Reduction Act of 1995,
Public Law 104–13), the Health
Resources and Services Administration
(HRSA) publishes periodic summaries
of proposed projects being developed
for submission to the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
To request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Reports Clearance
Officer at (301) 443–1984.
HRSA especially requests comments
on: (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
function, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
SUMMARY:
Information Collection Request Title:
Survey of Eligible Users of the National
Practitioner Data Bank and the
Healthcare Integrity and Protection
Data Bank (OMB No. 0915–xxxx)—New
Abstract: The Health Resources and
Services Administration (HRSA) plans
to conduct a survey of the National
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Practitioner Data Bank and the
Healthcare Integrity and Protection Data
Bank (NPDB/HIPDB). The purpose of
this survey is to assess the overall
satisfaction of the eligible users of the
NPDB/HIPDB. This survey will evaluate
the effectiveness of the NPDB/HIPDB as
flagging systems, sources of information,
and use in decision making.
Furthermore, this survey will collect
information from eligible non-users of
the NPDB/HIPDB to understand what
can be done to aid the eligible non-users
in registering, accessing, and using the
information available in the NPDB/
HIPDB. This survey is a follow-up to the
NPDB/HIPDB users and non-users
survey of 2008.
The survey will be administered to
eligible users of the NPDB/HIPDB. The
survey will also collect information
from those that have had matched
responses. A matched response occurs
when an eligible user queries the NPDB/
HIPDB then receives a report. The
purpose of collecting the matched
response data is to understand what
actions or decisions are made when an
eligible user receives a matched
response.
The survey will be administered to
non-users of the NPDB/HIPDB. Nonusers of the NPDB/HIPDB are
considered eligible users that have (i)
never registered, (ii) registered in the
past but are not currently registered, or
(iii) are registered but are not using the
NPDB/HIPDB. The information
provided by the non-users will enable
understanding of what needs to be done
to facilitate and educate non-users on
accessing and using the information in
the NPDB/HIPDB. Finally, the survey
will be administered to those that use
the self-query service provided by the
NPDB/HIPDB. Understanding self-query
user satisfaction and how the
information is used is an important
component of the survey.
Eligible users of the NPDB/HIPDB
will be asked to complete a web-based
survey. Eligible non-users that have
never registered in the NPDB/HIPDB
will be contacted via telephone to
obtain email information so that they
will be able to complete a web-based
survey. Data gathered from the survey
will be compared with previous survey
results. This survey will provide HRSA
with the information necessary to
improve the usability and effectiveness
of the NPDB/HIPDB.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions, to
develop, acquire, install and utilize
E:\FR\FM\26DEN1.SGM
26DEN1
76053
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Notices
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information, to train
personnel and to be able to respond to
Collection Request are summarized in
the table below.
The annual estimate of burden is as
follows:
a collection of information, to search
data sources, to complete and review
the collection of information, and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Average burden per response
(in hours)
Number of respondents
Number of responses per
respondent
Users Non-Matched Responses ...................
Users Matched Responses ..........................
Self-Query Non-Matched Responses ...........
Self-Query Matched Responses ...................
Non-Users (Hospitals) ..................................
Non-Users (All Others) .................................
11,832
1,768
1,080
120
1,200
400
1
1
1
1
1
1
11,832
1,768
1,080
120
1,200
400
0.25
0.25
0.10
0.10
0.10
0.10
2,958
442
108
12
120
40
Total ..............................................................................
16,400
........................
16,400
........................
3,680
Form name
NPDB/HIPDB
NPDB/HIPDB
NPDB/HIPDB
NPDB/HIPDB
NPDB/HIPDB
NPDB/HIPDB
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–29,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857.
Deadline: Comments on this
Information Collection Request must be
received within 60 days of this notice.
ADDRESSES:
Dated: December 17, 2012.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2012–30835 Filed 12–21–12; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Pediatric Palliative Care
Campaign Pilot Survey
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Nursing Research
(NINR), the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
SUMMARY:
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact Ms. Adrienne Burroughs, Health
Communications Specialist, Office of
Communications and Public Liaison,
NINR, NIH, Building 31, Room 5B10, 31
Center Drive, Bethesda, MD 20892, or
call non-toll-free number (301) 496–
0256, or Email your request, including
your address to:
adrienne.burroughs@nih.gov.
Comments regarding this information
collection are best assured of having
their full effect if received within 60days of the date of this publication.
Proposed Collection: Pediatric
Palliative Care Campaign Pilot Survey–
0925-New–National Institute of Nursing
Research (NINR), National Institutes of
Health (NIH).
Need and Use of Information
Collection: NINR developed a Pediatric
Total responses
Total burden
hours
Palliative Care Campaign to address the
communications challenges faced by
health care providers who recommend
and provide palliative care to pediatric
populations. NINR is launching this
effort to increase the use of palliative
care for children living with serious
illness or life-limiting conditions. The
Pediatric Palliative Care Campaign Pilot
Survey will assess the information and
materials being disseminated as part of
the Pediatric Palliative Care Campaign
pilot. Survey findings will help (1)
determine if the pilot campaign is
effective, relevant, and useful to health
care providers who recommend and
provide palliative care to pediatric
populations; (2) to better understand
current perceptions, challenges, and
information needs of health care
providers when it comes to discussing
pediatric palliative care so that
information and materials can be
refined; and (3) examine how effective
the campaign pilot materials are in
starting and continuing a pediatric
palliative care conversation and
addressing the communications needs
of health care providers around this
topic.
This assessment will deliver strategic
and actionable guidance for refining the
campaign materials so that they can be
used by a wider audience of health care
providers. OMB approval is requested
for 3 years. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 26.
tkelley on DSK3SPTVN1PROD with
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Physicians ........................................................................................
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06:31 Dec 22, 2012
Jkt 229001
Number of
responses per
respondent
Number of
respondents
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25
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E:\FR\FM\26DEN1.SGM
Average burden
per response
(in hours)
1
30/60
26DEN1
Total annual
burden hour
13
]]>Agencies
[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76052-76053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30835]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Public Law 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, email paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1984.
HRSA especially requests comments on: (1) The necessity and utility
of the proposed information collection for the proper performance of
the agency's function, (2) the accuracy of the estimated burden, (3)
ways to enhance the quality, utility, and clarity of the information to
be collected, and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
Information Collection Request Title: Survey of Eligible Users of the
National Practitioner Data Bank and the Healthcare Integrity and
Protection Data Bank (OMB No. 0915-xxxx)--New
Abstract: The Health Resources and Services Administration (HRSA)
plans to conduct a survey of the National Practitioner Data Bank and
the Healthcare Integrity and Protection Data Bank (NPDB/HIPDB). The
purpose of this survey is to assess the overall satisfaction of the
eligible users of the NPDB/HIPDB. This survey will evaluate the
effectiveness of the NPDB/HIPDB as flagging systems, sources of
information, and use in decision making. Furthermore, this survey will
collect information from eligible non-users of the NPDB/HIPDB to
understand what can be done to aid the eligible non-users in
registering, accessing, and using the information available in the
NPDB/HIPDB. This survey is a follow-up to the NPDB/HIPDB users and non-
users survey of 2008.
The survey will be administered to eligible users of the NPDB/
HIPDB. The survey will also collect information from those that have
had matched responses. A matched response occurs when an eligible user
queries the NPDB/HIPDB then receives a report. The purpose of
collecting the matched response data is to understand what actions or
decisions are made when an eligible user receives a matched response.
The survey will be administered to non-users of the NPDB/HIPDB.
Non-users of the NPDB/HIPDB are considered eligible users that have (i)
never registered, (ii) registered in the past but are not currently
registered, or (iii) are registered but are not using the NPDB/HIPDB.
The information provided by the non-users will enable understanding of
what needs to be done to facilitate and educate non-users on accessing
and using the information in the NPDB/HIPDB. Finally, the survey will
be administered to those that use the self-query service provided by
the NPDB/HIPDB. Understanding self-query user satisfaction and how the
information is used is an important component of the survey.
Eligible users of the NPDB/HIPDB will be asked to complete a web-
based survey. Eligible non-users that have never registered in the
NPDB/HIPDB will be contacted via telephone to obtain email information
so that they will be able to complete a web-based survey. Data gathered
from the survey will be compared with previous survey results. This
survey will provide HRSA with the information necessary to improve the
usability and effectiveness of the NPDB/HIPDB.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions, to develop, acquire, install and utilize
[[Page 76053]]
technology and systems for the purpose of collecting, validating and
verifying information, processing and maintaining information, and
disclosing and providing information, to train personnel and to be able
to respond to a collection of information, to search data sources, to
complete and review the collection of information, and to transmit or
otherwise disclose the information. The total annual burden hours
estimated for this Information Collection Request are summarized in the
table below.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
NPDB/HIPDB Users Non-Matched 11,832 1 11,832 0.25 2,958
Responses......................
NPDB/HIPDB Users Matched 1,768 1 1,768 0.25 442
Responses......................
NPDB/HIPDB Self-Query Non- 1,080 1 1,080 0.10 108
Matched Responses..............
NPDB/HIPDB Self-Query Matched 120 1 120 0.10 12
Responses......................
NPDB/HIPDB Non-Users (Hospitals) 1,200 1 1,200 0.10 120
NPDB/HIPDB Non-Users (All 400 1 400 0.10 40
Others)........................
-------------------------------------------------------------------------------
Total....................... 16,400 .............. 16,400 .............. 3,680
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10-29, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857.
Deadline: Comments on this Information Collection Request must be
received within 60 days of this notice.
Dated: December 17, 2012.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2012-30835 Filed 12-21-12; 8:45 am]
BILLING CODE 4165-15-P
